SYF9ac39ba3d83d4d00bd4e52d57de200ffRegistry ID: 2024-515989-14-00|RecruitingPhase 2
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interventional
N/A
1 country
8
Treatment compliance in an NBCCS - population / sporadic BCC patients in EADO stage IIb treated for 16 weeks with daily sonidegib followed by a pulsed dosing schedule maintained for the next 24 weeks.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2024
Actual (reported)A discontinuation rate <54% due to AEs at 40 weeks from study entry in a NBCCS - population/sporadic BCC patients in EADO stage IIb treated for 16 weeks with daily sonidegib followed by a pulsed dosing for the subsequent 24 weeks.
The ORR according to RECIST criteria.
The PFS at 40 weeks from study entry.
The DOR of a pulsed sonidegib regimen.
The rate of any grade drug related (DR) AEs and G3/4 DR AEs of a pulsed sonidegib regimen in a NBCCS - population / sporadic BCC patients in EADO stage IIb after 16 weeks with daily sonidegib.
The EORTC QLQ C30 score at baseline, after 16 weeks of continuous daily sonidegib therapy, and after 24 weeks of pulsed sonidegib regimen.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Odomzo 200 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Odomzo 200 mg hard capsules
Named ingredient: sonidegib
View registry recordAzienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Turin, 10126, Italy
Istituto Europeo Di Oncologia S.r.l.
Milan, 20141, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, 80131, Italy
Paolo Bossi
First Submitted
October 22, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
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Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, 40138, Italy
Humanitas Mirasole S.p.A.
Rozzano, 20089, Italy
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, 80131, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, 34128, Italy